Safe urinary catheter and manufacturing method

ABSTRACT

A urinary catheter may include a catheter shaft and a connector coupled with the proximal end of the catheter shaft. The connector may have a first arm ending in a fluid outlet configured to allow urine to flow out of the urinary catheter and a second arm with an aperture and ending in an inflation inlet used for introducing inflation fluid into the urinary catheter. The catheter may further include a primary lumen, an inflation lumen, a retention balloon mounted to the catheter shaft proximal to a fluid inlet and over a distal filling hole, and a pilot balloon mounted on the second arm of the connector over the aperture. The pilot balloon inflates at an inflation pressure that is higher than the inflation pressure of the retention balloon and lower than a predetermined pressure threshold.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/484,911, filed Apr. 11, 2017, entitled “Safe Urinary Catheter andManufacturing Method,” which claims the benefit of U.S. ProvisionalPatent Application No. 62/321,423, filed Apr. 12, 2016, entitled,“Manufacturing a Safe Urinary Catheter.” The entireties of eachapplication above are herein incorporated by reference.

TECHNICAL FIELD

This application is related to medical devices and methods. Morespecifically, this application is related to a safe urinary catheter anda method of manufacturing the catheter.

BACKGROUND

A urinary catheter is generally a thin, flexible tube, inserted into theurethra and advanced into the urinary bladder, in order to drain thebladder in patients who cannot urinate normally. For example, urinarycatheters are used during surgery, when a patient is under generalanesthesia, in some hospital patients to monitor urinary output, and inawake patients with any of a large number of voiding abnormalities, suchas urinary tract obstructions, urinary incontinence, and the like.

Indwelling urinary catheters, designed to remain in place for a longerperiod of time to drain the bladder, include at least two tubes runningin parallel. One of the two tubes is a “drainage tube,” with a hole atits distal end and a “drainage port” at its proximal end. Urine flowsinto the hole at the distal end of the drainage tube and out of thedrainage port to void the bladder. The second of the two tubes of anindwelling catheter is an inflation tube, which is in fluidcommunication with an inflatable balloon (often referred to as a“retention balloon”) at or near the distal end of the catheter. Theretention balloon is inflated within the urinary bladder to maintain theposition of the distal end of the catheter within the bladder. Theinflation tube (or “balloon tube”) generally terminates proximally at aninflation port (or “balloon port”). The inflation tube typicallyincludes a valve, allowing instillation or removal of liquid into orfrom the balloon (e.g., via a syringe). The balloon diameter, wheninflated, is larger than the urethral diameter, thus preventing theinflated balloon from slipping out of the bladder. Each of the two tubesof the indwelling urinary catheter may terminate either outside thepatient's body or inside the body, depending on the specific medicalapplication. For example, in some embodiments, the drainage tube can belinked to a urine collection bag.

Unlike most medical devices, urinary catheters are most commonly placedinto and removed from patients by nurses, ancillary medical staff, andpatients themselves. Unfortunately, incorrect handling and placement ofurinary catheters can result in disastrous consequences, and physiciansand non-physicians alike report frequent complications associated withplacement and removal of urinary catheters. Indeed, urologists areregularly consulted to manage complications associated with misplacementof urinary catheters. A common complication is damage to the urethra(and extreme pain, if the patient is awake) when the balloon at the tipof the catheter is inflated (accidentally) while it resides in theurethra rather than in the bladder. This occurs when the person placingand inflating the catheter has not inserted it far enough through theurethra. This situation can create significant urethral injury, pain andbleeding, and typically necessitates a costly consultation by a surgicalspecialist. The catheter can usually be replaced after the injury, butmay require invasive cystoscopy (placement of a small camera into theurethra). Invariably, in this situation, the catheter must remainindwelling for a longer than intended time period, to allow the urethrato heal and/or to provide pressure to halt the bleeding. Otherconsequences of intra-urethral balloon inflation are urinary tractobstruction, urinary tract infections, discomfort, renal failure, anddeath. The urethral injury may also result in urethral stricture ornarrowing, which can necessitate additional costly surgicalinterventions.

Another common complication associated with urinary catheters occurswhen the catheter balloon bursts inside the patient's bladder. Balloonburst may occur for a variety of reasons, most commonly overfilling ofthe balloon or device malfunction (e.g., defective balloon). Afterballoon burst in the bladder, the catheter slides out of the urethra andmust be replaced. More significantly, studies have shown that uponbursting, a fragment of the balloon wall frequently breaks away from theshaft of the catheter and remains within the bladder. The balloonfragment must be retrieved, e.g., by a surgical specialist with the aidof a cystoscope. If the fragment is not removed, the patient may havesevere urinary symptoms, such as recurrent urinary tract infections andstone formation, which require further medical intervention and expense.

Another common failure of urinary catheters is a balloon that will notdeflate. Current recommendations for managing a non-deflating ballooninclude percutaneous or endoscopic balloon puncture, instillation ofchemicals to dissolve the balloon, or over-inflating the balloon toburst it. These techniques, while necessary, can result in balloonfragmentation, patient discomfort, bleeding, and damage to nearbyorgans.

Yet another complication occurs when a patient or healthcareprofessional attempts to remove the catheter, or the catheter isaccidentally pulled out, while the balloon is still partially orcompletely inflated. For example the patient or healthcare professionalmight believe the balloon is deflated when it actually is not, thecatheter tubing may snag on another object and get yanked out, a patientwith altered mental status may pull out the inflated catheter, etc. Theresult of pulling out an inflated catheter is similar to that ofinflating the balloon within the urethra, but typically more severe,because it may damage the entire length of the urethra. Furthercomplicating premature catheter removal is the necessity to replace thecatheter through an already damaged urethra, and possible disruption insome cases of a still healing surgical repair (i.e., after removal ofthe prostate for cancer or repair of a urethral stricture).

Based on these issues and complications with urinary catheters, it wouldbe very desirable to have catheters that are safer to use and that havea lower likelihood of complications due to misuse or malfunction of theballoon on the catheter. Ideally, such catheters would also berelatively easy to place and inflate, so that a wide variety ofhealthcare professionals, staff and even patients could use them withlittle or no additional training.

SUMMARY

The present disclosure describes a urinary catheter with improved safetyfeatures, a method for making the urinary catheter, and a method forusing the catheter. The catheter and the methods for manufacturing andusing it are described in terms of a number of different embodiments,none of which are intended to limit the scope of the disclosure.

In one aspect of the disclosure, a urinary catheter may include anelongate, flexible, tubular catheter shaft having a proximal end and adistal end and a connector coupled with the proximal end of the cathetershaft. The connector may have a first arm ending in a fluid outletconfigured to allow urine to flow out of the urinary catheter and asecond arm with an aperture and ending in an inflation inlet used forintroducing inflation fluid into the urinary catheter. The catheter mayalso include a primary lumen extending through the catheter shaft from afluid inlet at or near the distal end of the catheter shaft to the firstarm of the connector, an inflation lumen extending through the cathetershaft from a distal filling hole in the catheter shaft to the second armof connector, a retention balloon mounted to the catheter shaft proximalto the fluid inlet and over the distal filling hole and a pilot balloonmounted on the second arm of the connector over the aperture. Theretention balloon is configured to inflate at a first inflationpressure, and the pilot balloon is configured to inflate at a secondinflation pressure that is higher than the first inflation pressure andlower than a predetermined pressure threshold.

In various embodiments, the aperture in the second arm of the connectormay be one hole, multiple holes, a slit, a gap between two portions ofthe second arm or the like. In some embodiments, a cross-sectional areaof the aperture in the second arm of the connector may be less than across-sectional area of the distal filling hole. In some embodiments,the catheter may further include a check valve attached to a proximalend of the second arm, and the inflation inlet may be a proximal end ofthe check valve.

According to various embodiments, any one or a combination ofdifferences between the retention balloon and the pilot balloon mayaccount for their different inflation pressures. For example, in someembodiments, the retention balloon has a first balloon wall thickness,and the pilot balloon has a second balloon wall thickness that isgreater than the first balloon wall thickness. In some embodiments, theretention balloon is made of a first material having a first durometer,and the pilot balloon is made of a second material having a seconddurometer that is greater than the first durometer. In some embodiments,the retention balloon has a first length, and the pilot balloon has asecond length that is different than the first length. In someembodiments, the retention balloon has a first radius, and the pilotballoon has a second radius that is less than the first radius. In someembodiments, the pilot balloon is shaped as a tube, and the retentionballoon has a preformed balloon shape, so that a higher pressure isrequired to begin inflating the pilot balloon than the retentionballoon. In some embodiments, the retention balloon has a first inflatedshape, and the pilot balloon has a second inflated shape that isdifferent than the first inflated shape.

Optionally, any of the embodiments may include further comprising aradiopaque strip extending through at least a portion of the cathetershaft.

In another aspect of the disclosure, a method of manufacturing a urinarycatheter may involve providing an elongate, flexible, tubular cathetershaft having a proximal end, a distal end, a primary lumen extendingthrough the catheter shaft from a fluid inlet at or near the distal endof the catheter shaft to the proximal end of the catheter shaft, and aninflation lumen extending through the catheter shaft from a distalfilling hole near the distal end of the catheter shaft to the proximalend of the catheter shaft. The method may also include attaching aconnector with the proximal end of the catheter shaft. The connector mayinclude a first arm in fluid communication with the primary lumen andending in a fluid outlet configured to allow urine to flow out of theurinary catheter and a second arm with an aperture in fluidcommunication with the inflation lumen and ending in an inflation inletused for introducing inflation fluid into the urinary catheter. Next,the method may include mounting a retention balloon on the cathetershaft over the distal filling hole and proximal to the fluid inlet andmounting a tubular pilot balloon on the second arm of the connector overthe aperture in the second arm. Again, the retention balloon isconfigured to inflate at a first inflation pressure, and the pilotballoon is configured to inflate at a second inflation pressure that ishigher than the first inflation pressure and lower than a predeterminedpressure threshold.

Optionally, the method may also include forming the aperture in thesecond arm. For example, forming the aperture may involve forming atleast one of a hole, a slit or a cut in the second arm. In someembodiments, a cross-sectional area of the aperture in the second arm isless than a cross-sectional area of the distal filling hole.

In some embodiments, the method may also include forming the tubularpilot balloon to have a tubular shape and forming the retention balloonto have a preformed balloon shape, such that a higher pressure isrequired to begin inflating the tubular pilot balloon than the retentionballoon. In some embodiments, the method may also include forming theretention balloon to have a first balloon wall thickness and forming thepilot balloon to have a second balloon wall thickness that is greaterthan the first balloon wall thickness. In some embodiments, the methodmay also include forming the retention balloon out of a first materialhaving a first durometer and forming the pilot balloon out of a secondmaterial having a second durometer that is greater than the firstdurometer. In some embodiments, the method may also include forming theretention balloon to have a first length and forming the pilot balloonto have a second length that is different than the first length. In someembodiments, the method may also include forming the retention balloonto have a first inflated shape and forming the pilot balloon to have asecond inflated shape that is different than the first inflated shape.

In yet another aspect of the disclosure, a method of positioning aurinary catheter in a patient may involve: advancing a distal end of theurinary catheter through the patient's urethra; introducing inflationfluid into the urinary catheter to inflate a retention balloon at ornear the distal end of the urinary catheter; observing that a pilotballoon at or near a proximal end of the urinary catheter, locatedoutside the patient, has inflated; waiting for at least a predefinedamount of time for the pilot balloon to deflate; and if the pilotballoon deflates during the predefined amount of time, then leave theurinary catheter in place within the patient. If the pilot balloon doesnot deflate during the predefined amount of time, then the method mayinvolve removing the inflation fluid from the urinary catheter andrepositioning or removing the urinary catheter.

In some embodiments, the predefined amount of time may be a range ofbetween 3 and 30 seconds. For example, in one embodiment, the predefinedamount of time may be ten seconds. In some embodiments, introducing theinflation fluid may involve injecting the inflation fluid with a syringeattached to an inflation port at or near the proximal end of the urinarycatheter. In some embodiments, introducing the inflation fluid mayinvolve injecting between 5 cc and 10 cc of the inflation fluid. In someembodiments, the method may further involve visualizing at least theadvancing step via a radiographic imaging device and a radiopaque stripor marker on the urinary catheter.

These and other aspects and embodiments will be disclosed in furtherdetail below, in reference to the attached drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of a urinary catheter, according to oneembodiment;

FIG. 1B is a side view of the catheter of FIG. 1A, with a cut-out,cross-sectional view along the length of the catheter shaft;

FIG. 1C is a top view of a distal portion of the catheter of FIGS. 1Aand 1B;

FIG. 1D is a side, cross-sectional view of the pilot balloon portion ofthe catheter of FIGS. 1A-1C;

FIG. 2 is a graph showing a radius/pressure curve of an inflatingballoon, according to one embodiment;

FIG. 3 is a graph showing a balloon wall thickness/pressure curve of aninflating balloon, according to one embodiment;

FIGS. 4A and 4B are perspective views of a proximal end of a urinarycatheter, illustrating a method for assembling the proximal portion,according to one embodiment; and

FIGS. 5A and 5B are perspective views of a proximal end of a urinarycatheter, illustrating a method for assembling the proximal portion,according to an alternative embodiment.

DETAILED DESCRIPTION

The present application describes an improved urinary catheter withsafety features designed to help prevent catheter-related injuries dueto improper inflation, improper removal, balloon burst due toover-inflation and/or the like. The application also describes methodsfor making and using such a catheter. The embodiments include a reliefballoon (also called a “pilot balloon”) on the proximal portion of theurethral catheter that resides outside the body. The pilot balloon willrelieve pressure from the distal balloon, if the latter is inflatedwithin the urethra. The pilot balloon will typically have a fillingpressure that is slightly higher than that of the retention balloon. Inthis way, the pilot balloon fills only when the retention balloon issubject to greater than expected filling pressures. One example of aurinary catheter with a relief balloon is described in U.S. Pat. No.9,084,868, which is hereby incorporated by reference in its entiretyherein.

For the purposes of this application, unless indicated otherwise, theterms “proximal” and “distal” refer to positions relative to outside ofa body into which a catheter is inserted. Accordingly, when inserted ina subject (e.g., a human), the proximal end of a catheter is typicallyoutside of the subject's body, and the distal end of the catheter istypically within the body, for example within the bladder. The terms“subject” and “patient” are used synonymously herein and refer to ahuman or animal subject.

Referring to FIGS. 1A-1D, one embodiment of a urinary catheter 100 isillustrated. FIG. 1A is a side view of catheter 100. FIG. 1B is anenlarged, side view of catheter 100 with a section removed from thecatheter shaft and with a cross-sectional view of the shaft. FIG. 1C isa top view of a distal portion of catheter 100. FIG. 1D is a side,cross-sectional view of the pilot balloon portion of catheter 100. Inthe illustrated embodiment, catheter 100 includes an elongate, flexible,catheter shaft 102 with a rounded distal tip 116, a connector 104attached to the proximal end of shaft 102, and a retention balloon 114near the distal end of shaft 102. A first arm of connector 104 ends in afluid outlet 105, through which urine exits catheter 100. A second armof connector 104 includes a pilot balloon 108 mounted on a tube 106, andproximal to that a check valve 112 with a sleeve 110. Shaft 102 alsoincludes an inflation lumen 120 (FIGS. 1B and 1C), for inflatingretention balloon 114, a primary lumen 122 (or “emptying” or “voiding”lumen), for passage of urine out of the bladder through catheter 100,and a distal hole 124 (FIG. 1C, also called a “fluid inlet”), throughwhich urine enters primary lumen 122 from the bladder. Optionally, shaft102 may also include a radiopaque strip 118 along all or part of itslength, to facilitate radiographic visualization of catheter 100.

Retention balloon 114 is attached to a distal portion of shaft 102,proximal to hole 124. As mentioned above, connector 104 includes fluidoutlet 105 (or “urine voiding/emptying end”) on one arm and tube 106attached to the other arm. Tube 106, in turn, is connected to a checkvalve 112. A pilot balloon 108 is mounted on tube 106, and tube 106includes one or more apertures 126 (FIG. 1D), through which inflationfluid can flow to inflate pilot balloon 108 if the required inflationpressure is reached inside tube 106. Aperture(s) 126 may be one hole, asshown, multiple holes, a slit, an opening between two sections of tube106, or any other opening or openings in tube 106. Sleeve 110, which ismounted on check valve 112, may optionally include any suitablelabeling, such as but not limited to a size and/or volume label.

As shown in the cross-sectional cut-outs of FIGS. 1B and 1C, inflationlumen 120 may be located within the wall of catheter shaft 102, andprimary lumen 122 may be formed by an inner surface of the wall ofcatheter shaft 102. Alternatively, both lumens 120, 122 may be locatedwithin the wall of the catheter in some embodiments. In otherembodiments, urinary catheter 100 may include two catheter shafts thatrun in parallel and are connected, with one shaft forming aprimary/emptying lumen and the other shaft forming an inflation lumen.

Referring to FIG. 1D, tube 106 and pilot balloon 108 may be attached atone end to connector 104 and at an opposite end to check valve 112. Anysuitable means for attachment may be used, such as but not limited toglue or thermal bonding. In many embodiments, the second arm ofconnector 104 may simply be a tube branching off of connector 104 andmay not include a separate tube 106. In those embodiments, examples ofwhich are pictured in FIG. 4A-5B, aperture 126 (or multiple apertures, aslit, a gap, or the like) are simply located in the second arm ofconnector 104. As mentioned above, tube 106 may include aperture 126 insome embodiments, as shown, leading from the lumen of tube 106 to aninner surface of pilot balloon 108. If sufficient fluid pressure buildsup within tube 106, fluid will exit through aperture 126 and inflateballoon 108. In alternative embodiments, tube 106 may include more thanone aperture 126. In other alternative embodiments, other mechanisms intube 106 may be used. For example, in one embodiment tube 106 may be intwo pieces or may include a longitudinal slit, to allow fluid to flowtherethrough. In the embodiment illustrated in FIG. 1D, only oneaperture 126 is included in tube 106. In one embodiment, the aperture126 has a diameter of about 1 mm.

In various embodiments, any suitable material or combination ofmaterials may be used to make urinary catheter 100. For example, in someembodiments, catheter 100 may be made completely or primarily out oflatex or silicone. In one embodiment, for example, all the components ofcatheter 100 described above are made of silicone, other than sleeve 110and check valve 112. For example, sleeve 110 may also be made ofsilicone, but in one embodiment it is made of acrylonitrile butadienestyrene (ABS). In one embodiment, check valve 112 may also be made ofsilicone, but alternatively it may be made of silicone or one or moreother plastic materials. Radiopaque strip 118 may be made of anysuitable, biocompatible radiopaque material.

FIG. 1C, which again is a top view of a distal portion of urinarycatheter 100, clearly shows fluid inlet 124 and distal tip 116. Fluidinlet 124 may have any suitable size and shape, for example the ovoidshape pictured here. In one embodiment, fluid inlet is approximately 5.5mm long and 2.5 mm wide. Distal tip 116 may be a Tiemann or Coude tip,for example. Also visible in FIG. 1C (as well as in FIGS. 1A and 1B) isa retention balloon inflation hole 128, which is in fluid communicationwith balloon inflation lumen 120 and which allows inflation fluid toflow into retention balloon 114. In one embodiment, retention ballooninflation hole 128 has a diameter of about 1 mm.

In various embodiments, any of the components of urinary catheter 100may have any of a number of suitable dimensions. Merely by way ofexample, several dimensions of components have been mentioned above.Also for exemplary purposes only (and not to be considered limiting),additional dimensions of one embodiment of urinary catheter 100 include:420 mm+/−2 mm from distal tip 116 to fluid outlet 105; length ofretention balloon 114 16 mm+/−2 mm; diameter of retention ballooninflation lumen 120 about 1 mm; inner diameter of tube 106 4 mm+/−0.2mm; length of pilot balloon 31 mm+/−1 mm; outer diameter of pilotballoon 7.6 mm+/−0.2 mm. Again, these are only examples of dimensionsfor one embodiment of urinary catheter 100 and are not meant to limitthe scope of the invention.

In use, distal tip 116 of catheter 100 is advanced through the urethraand into the urinary bladder, and retention balloon 114 is inflated withinflation fluid via an inflation device, such as a syringe (notillustrated) attached to the end of check valve 112. If retentionballoon 114 is located in the urethra and not the bladder when the userattempts to inflate it, fluid pressure will quickly build up within tube106, and pilot balloon 108 will inflate, thus relieving pressure fromthe retention balloon 114 and alerting the user that retention balloon114 is not in the bladder. As such, pilot balloon 108 should require ahigher threshold opening pressure and/or resting capacity pressure thanretention balloon 114. In other words, it should be harder to inflatepilot balloon 108 than retention balloon 114. In various embodiments ofurinary catheter 100, for example, pilot balloon 108 has a 15%-75%higher threshold opening pressure and/or resting capacity pressure thanretention balloon 114. At the same time, in most embodiments pilotballoon 108 will begin to inflate at a pressure that is below apredetermined threshold pressure that has been designed to enhancesafety of urinary catheter 100. In other words, pilot balloon 108inflates within a predetermined pressure range, with an opening pressurethat is higher than that of retention balloon 114 but below thepredetermined threshold pressure.

There are a number of ways to manufacture urinary catheter 100 so thatpilot balloon 108 has a desired opening pressure relative to retentionballoon 114 (and thus inflates as desired). For example, the materialused to make pilot balloon 108 is one important variable. In oneembodiment, for example, a higher durometer (harder) material may beused to make pilot balloon 108 than retention balloon 114, thusrequiring a higher pressure to inflate pilot balloon 108. In someembodiments, however, much or all of urinary catheter 100, includingboth pilot balloon 108 and retention balloon 114, is made of silicone ofthe same durometer. In such embodiments, the material for both balloons108, 114 is the same, so the material does not create the pressuredifferential.

Another way to give pilot balloon 108 a higher inflation pressure thanthat of retention balloon 114 is to make the wall of pilot balloon 108thicker than the wall of retention balloon 114. As just one,non-limiting example, in one embodiment, pilot balloon 108 may have awall thickness of 0.8 mm+/−0.05 mm, while retention balloon 114 may havea wall thickness of less than 0.8 mm, for example a common retentionballoon thickness is 0.5 mm+/−0.05 mm. The thicker wall of pilot balloon108 will require more pressure to expand than will the wall of retentionballoon 114.

Another way to provide variation in inflation pressures between the twoballoons 108, 114 is to give the balloons 108, 114 different sizesand/or shapes. In an ideal balloon, the pressure (P) is equal to 2 timesthe surface tension divided by the balloon radius (P=2*u/R). The surfacetension should be the same between spherical balloons, assuming allproperties other than size are equal. Therefore, balloon pressure isinversely proportional to the radius, and a smaller radius balloon shapewill require a higher pressure to inflate. In one specific embodiment,retention balloon 114 may be a 5 cc balloon, and pilot balloon 108 maybe a 3 cc balloon. For example, in this embodiment, the radius of the 5cc balloon retention balloon 114 may be about 1.05 cm, and the radius ofthe 3 cc pilot balloon 108 may be about 0.89 cm. In this case, thesmaller pilot balloon 108 will require 18% higher pressure to inflate,based on volume relations.

The shapes of the balloons 108, 114 may also be different. For example,in one embodiment of urinary catheter 100, pilot balloon 108 has atubular shape when not inflated—in other words, it is not pre-shaped asa balloon. In contrast, retention balloon 114 may be pre-shaped as aballoon, and for example may be folded or pleated when in its resting,uninflated state. Additionally, the balloons 108, 114 may have differentinflated shapes as well. For example, one of the balloons 108, 114 maybe round when inflated, while the other may have an ovoid, ring-like orother inflated shape.

An initial (or “peak) pressure is required to inflate any balloon. For astandard balloon, the peak pressure is typically 10%-25% higher than itsresting pressure—i.e., the static pressure in the balloon once it isinflated to its desired size. For example, this is why, when you inflatea party balloon, you initially need to breathe a little bit harder toget the inflation of the balloon started than you do when you areinflating the balloon the rest of the way. When you inflate a balloonthat has an initial, uninflated shape of a cylinder, rather than aballoon with an ovoid or round shape, you need to breathe extra-hard atthe beginning. In most embodiments of urinary catheter described herein,pilot balloon 108 is cylindrical. Because pilot balloon 108 does nothave an initial or uninflated “balloon shape,” the peak pressure forpilot balloon 108 may range from 40-75% higher than its restingpressure. This is important, because it prevents “accidental” or “false”inflation of pilot balloon 108. An example of an accidental inflationwould be if a urinary catheter were properly placed in the bladder, andonly retention balloon 114 should inflate, but instead pilot balloon 108also inflates. Such inflation sends a false signal to the user and isimportant to avoid for proper functionality.

In one embodiment, the resting pressure of pilot balloon 108 isapproximately 15% higher than the resting pressure of retention balloon114 (80-90 Kpa for pilot balloon 108 vs. 70 kpa for retention balloon114). The threshold for urethral damage/trauma is considered to bearound 150 Kpa. In one embodiment, pilot balloon 108 will have a peakpressure (or “predetermined pressure threshold”) of less than or about100 Kpa, so that it will start to inflate at that pressure. A standardexisting catheter improperly placed will create pressures in excess of500 Kpa in the urethra, well above this threshold for damage.

Yet another way to regulate the relative inflation pressures of pilotballoon 108 and retention balloon 114 is to select the size of theinflations holes of the balloons 108, 114 according to desired inflationpressure characteristics. The “inflation hole” of a balloon generallyrefers to the hole through which the balloon is filled and through whichit empties. In some cases, the hole may be a slit or other opening inthe shaft or between shafts. In the case of retention balloon 114, theretention balloon filling hole 128 traverses through catheter shaft 102to connect inflation lumen 120 with the interior of retention balloon114. In the case of pilot balloon 108, aperture 126 traverses the wallof tube 106 to connect the interior of tube 106 with the interior ofpilot balloon 108. The pressure drop across a hole is equal to:

${\Delta \; P} = {2{f\left\lbrack \frac{L}{D} \right\rbrack}\left( {pxV}^{\; 2} \right)}$

This means that a smaller diameter hole will lead to a larger pressuredrop across the hole. Similarly, a filling slit or opening with asmaller cross-sectional area will lead to a larger pressure drop.Therefore, it follows that for a given balloon inflation pressure, agreater fill channel pressure would be required to blow up a balloonwith a smaller inflation hole. For example, if retention balloon 114 hasretention balloon filling hole 128 with a diameter of about 3 mm, andpilot balloon 108 has aperture 126 with a diameter of about 2 mm, itwould require 33% greater channel pressure to inflate pilot balloon 108than it would to inflate retention balloon 114. In other words, in thisexemplary embodiment, pilot balloon would not inflate until the channelpressure was 33% higher than that required to fill the retentionballoon.

Another way to regulate balloon inflation pressure is by the angle ofentry of the inflation hole into the balloon lumen. Before inflation ofpilot balloon 108, for example, the wall of pilot balloon 108 coversinflation aperture 126. If the angle of aperture 126 is flat (in otherwords, oriented perpendicularly to the wall of pilot balloon 108), thenthe wall of pilot balloon 108 will completely cover the wall of theaperture 126, and will result in a higher threshold opening pressure. Ifthe face of aperture 126 is oriented at an oblique angle to the wall ofpilot balloon 108 (when the balloon is completely empty), such that atrest the face of the aperture 126 is not in complete contact with theballoon wall, then the threshold filling pressure will be slightlylower, because the balloon wall is not directly obstructing the entireopening of aperture 126. The angle of an inflation hole can also affectthe emptying of a balloon. For example, when the filled balloon issubject to deforming stress, the balloon wall can obstruct theinflation/emptying hole, effectively increasing the pressure necessaryto empty the balloon. This design feature may be applied to pilotballoon 108, retention balloon 114 or both.

Some embodiments use a combination of features to create a desiredinflation pressure differential between pilot balloon 108 and retentionballoon 114. For example, in one embodiment, pilot balloon 108 andretention balloon 114 of urinary catheter 100 may have the followingdifferent characteristics: (1) different wall thickness (0.8 mm forpilot balloon 108 vs. 0.5 mm for retention balloon 114); (2) differentdurometer (40 shore A for pilot balloon 108 vs. 25 shore A for retentionballoon 114); and (3) different resting/uninflated shape (tube shape forpilot balloon 108 vs. pre-shaped balloon shape for retention balloon114). The above example, of course, is only one of many possibleembodiments. For example, in various embodiments, pilot balloon 108 mayhave a thickness of between about 0.6 mm and about 0.9 mm, or moregenerally pilot balloon 108 may have a thickness that is about 20% toabout 80% greater than retention balloon 114. The durometer of thematerial of pilot balloon 108 may range from equal to that of retentionballoon 114 to as much as about 50% greater than that of retentionballoon 114. Another factor, which may be used in addition to or as analternative to any of the above-listed factors, is that pilot balloon108 may be longer than retention balloon 114. Again, any suitablecombination of the above factors, measurements and characteristics maybe used, in various embodiments.

Referring now to FIG. 2, a graph 200 illustrates a radius/pressure curve202 for an idealized rubber balloon, according to one example. On graph200, the x-axis 204 indicates the ratio of the inflated radius to thenominal (uninflated) radius of the balloon, and the y-axis 206 indicatesthe relative pressure. Curve 202 reveals a way of creating a pressuredifference between the two. Pilot balloon 108, for example, could bedesigned such that it never makes it past the initial peak on the leftside of curve 202, while retention balloon 114 is inflated far past thispressure peak, resulting in a lower pressure. In practice, one couldachieve this using one or a combination of the above-described methodsof varying pressure. Curve 202 also shows that if retention balloon 114can be inflated past the peak pressure without inflating pilot balloon108, then pilot balloon 108 should not inflate, unless it is in thewrong location (such as the urethra), and its expansion is beingresisted.

Referring now to FIG. 3, a graph 300 illustrates a pressure/thicknesscurve 302 for an idealized rubber balloon, according to one example. Ongraph 300, the x-axis 304 indicates the wall thickness of the balloon inmillimeters, and the y-axis 306 indicates amount of pressure with whichthe balloon is being inflated. As the balloon increases in wallthickness 304, the pressure to inflate it 306 will rise. The pressure toinflate 306 follows an exponential curve 302. It is therefore importantto choose a thickness 304 below the exponential portion of the curve302, so that slight variations in thickness do not cause a drasticchange in the inflation pressure. In some embodiments, for example, thewall thickness 304 of pilot balloon 108 may be selected to achieve apoint just before the exponential portion of the curve, to maximize thedifference between pilot balloon 108 and retention balloon 114pressures, while optimizing reliability of pilot balloon 108. In onespecific embodiment, for example, pilot balloon 108 may be given a wallthickness of 0.85 mm.

FIGS. 4A and 4B illustrate one method for manufacturing (or“assembling”) a portion of urinary catheter 100. In this embodiment, thetube-shaped pilot balloon 108 is mounted directly over the second arm130 of connector 104, which includes aperture 126 that allows inflationfluid to pass from second arm 130 into pilot balloon 108. Sleeve 110 andcheck valve 112, which may be a one-piece construction, are then placedover the proximal end of pilot balloon 108. In this embodiment, in otherwords, second arm 130 acts as tube 106 from previously describedembodiments. This is simply an alternative embodiment—e.g., tube 106 maybe attached to a proximal end of a second arm in some embodiments, whilealternatively second arm 130 may be one piece, without a separate tube106 attached to it.

With reference now to FIGS. 5A and 5B, in an alternative embodiment, asecond arm of connector 104 may be cut into two second arm portions 132a, 132 b, leaving a gap 134 between the two. Pilot balloon 108 may bemounted over the two second arm portions 132 a, 132 b and gap 134, sothat gap 134 acts as the aperture through which inflation fluid flows tofill pilot balloon 108. This embodiment may allow a simplified assemblyprocess.

As illustrated in FIGS. 4A-5B and as described above, pilot balloon 108,in many embodiments, is shaped as a simple tube of material. Because atube, like pilot balloon 108, can be extruded, a large number of tubescan be produced very inexpensively. The only processing required iscutting the tube to length. Unlike a simple tube, a conventional balloonmust either be extruded and blown or dipped on a mandrel individually.Balloon blowing and dipping are both more expensive processes thanextruding and cutting tubes. Therefore, one advantage of the method ofmanufacturing urinary catheter 100 is that the simple tubular shape ofpilot balloon 108 and its assembly onto catheter 100 allow for very costeffective manufacturing. For example, some embodiments may have amanufacturing cost within approximately 10% of a cost of a conventionalcatheter with no safety features.

In various embodiments, a manufacturing method for making urinarycatheter 100 may include any of the design modifications and featuresdescribed above. For example, any of the different combinations offeatures, sizes, angles and/or wall thicknesses of pilot balloon 108,retention balloon 114, aperture 126 and/or retention balloon inflationhole 128 may be used, according to various alternative embodiments.Pilot balloon 108 and tube 106 may be glued onto connector 104 and checkvalve 112 in any suitable way and with any suitable amount of overlap.Similarly, retention balloon 114 may be glued or otherwise attached tocatheter shaft 102 in any suitable way and with any suitable amount ofoverlap.

In one embodiment, a method for positioning urinary catheter 100 mayfirst involve advancing distal tip 116 of urinary catheter 100 throughthe patient's urethra. Next, inflation fluid may be introduced intourinary catheter 100 via an inflation port on the end of check valve112, to inflate retention balloon 114. In some embodiments, for example,about 5 cc to about 10 cc of the inflation fluid, such as sterile water,sterile saline or the like, may be injected using a syringe. The usermay watch pilot balloon 108 during and/or after inflation. If the userobserves pilot balloon 108 does not inflate, then he/she may assumeretention balloon 114 has been safely inflated in the bladder.

If, on the other hand, pilot balloon 108 does inflate, even partially,the user may wait for at least a predefined amount of time to see ifpilot balloon 108 deflates. This may be a beneficial step in the method,because sometimes pilot balloon 108 may partially or even completelyinflate, even when retention balloon 114 is in the bladder. This mayoccur, for example, if the inflation fluid is injected into catheter 100very quickly and/or with a great deal of force. If pilot balloon 108deflates during the predefined amount of time, then the user may assumeretention balloon 114 is safely inflated in the bladder and may leavethe urinary catheter in place within the patient. If pilot balloon 108does not deflate during the predefined amount of time, then the user mayremove the inflation fluid from urinary catheter 100 (for example bypulling back the plunger on the inflation syringe) and either repositionor remove the urinary catheter from the patient. In various embodiments,the predefined amount of time may be any suitable amount of time, forexample as short as three seconds, as long as thirty seconds or even aminute or more, and in one embodiment about ten seconds. In someembodiments, the method may also include visualizing at least theadvancement of urinary catheter 100 via a radiographic imaging deviceand radiopaque strip 118 (or other radiopaque marker) on catheter 100.

Although various embodiments are described herein in detail, any of anumber of modifications may be made to any given embodiment, withoutdeparting from the scope of the invention as it is defined by thefollowing claims. Therefore, the description of embodiments herein isintended to be exemplary in nature and not limiting.

1. A urinary catheter for draining urine from a bladder of a patient,the urinary catheter comprising: an elongate, flexible, tubular cathetershaft having a proximal end and a distal end and consisting of silicone;a connector coupled with the proximal end of the catheter shaft, whereinthe connector comprises: a first arm ending in a fluid outlet configuredto allow urine to flow out of the urinary catheter; and a second armcomprising an aperture and ending in an inflation inlet used forintroducing inflation fluid into the urinary catheter; a primary lumenextending through the catheter shaft from a fluid inlet at or near thedistal end of the catheter shaft to the first arm of the connector; aninflation lumen extending through the catheter shaft from a distalfilling hole in the catheter shaft to the second arm of the connector; aretention balloon mounted to the catheter shaft proximal to the fluidinlet and over the distal filling hole, wherein the retention balloon ismade of silicone, has a non-tubular, preformed balloon shape when notinflated, and has a first wall thickness and a first durometer; and apilot balloon consisting of a tubular member mounted on the second armof the connector over the aperture in a location that is outside thepatient during use of the urinary catheter, wherein the pilot balloon ismade of silicone, has a tubular shape when not inflated and thus has ahigher threshold opening pressure than that of the retention balloon,and has a second wall thickness that is greater than the first wallthickness and a second durometer that is greater than the firstdurometer, wherein the retention balloon is configured to inflate at afirst inflation pressure, and the pilot balloon is configured to inflateat a second inflation pressure that is higher than the first inflationpressure and lower than a predetermined pressure threshold.
 2. Theurinary catheter of claim 1, wherein the aperture in the second arm ofthe connector is selected from the group consisting of one hole,multiple holes, a slit, and a gap between two portions of the secondarm.
 3. The urinary catheter of claim 1, wherein a cross-sectional areaof the aperture in the second arm of the connector is less than across-sectional area of the distal filling hole.
 4. The urinary catheterof claim 1, further comprising a check valve attached to a proximal endof the second arm, wherein the inflation inlet comprises a proximal endof the check valve.
 5. (canceled)
 6. (canceled)
 7. The urinary catheterof claim 1, wherein the retention balloon has a first length, and thepilot balloon has a second length that is different than the firstlength.
 8. The urinary catheter of claim 1, wherein the retentionballoon has a first radius, and the pilot balloon has a second radiusthat is less than the first radius.
 9. (canceled)
 10. The urinarycatheter of claim 1, wherein the retention balloon has a first inflatedshape, and the pilot balloon has a second inflated shape that isdifferent than the first inflated shape.
 11. The urinary catheter ofclaim 1, further comprising a radiopaque strip extending through atleast a portion of the catheter shaft.
 12. A method of manufacturing aurinary catheter for draining urine from a bladder of a patient, themethod comprising: providing an elongate, flexible, tubular cathetershaft having a proximal end and a distal end and consisting of siliconeand further comprising: a primary lumen extending through the cathetershaft from a fluid inlet at or near the distal end of the catheter shaftto the proximal end of the catheter shaft; and an inflation lumenextending through the catheter shaft from a distal filling hole near thedistal end of the catheter shaft to the proximal end of the cathetershaft; attaching a connector with the proximal end of the cathetershaft, wherein the connector comprises: a first arm in fluidcommunication with the primary lumen and ending in a fluid outletconfigured to allow urine to flow out of the urinary catheter; and asecond arm comprising an aperture in fluid communication with theinflation lumen and ending in an inflation inlet used for introducinginflation fluid into the urinary catheter; mounting a retention balloonon the catheter shaft over the distal filling hole and proximal to thefluid inlet, wherein the retention balloon is made of silicone, has anon-tubular, preformed balloon shape when not inflated, and has a firstwall thickness and a first durometer; and mounting a tubular pilotballoon consisting of a tubular member on the second arm of theconnector over the aperture in the second arm in a location that isoutside the patient during use of the urinary catheter, wherein thepilot balloon is made of silicone, has a tubular shape when not inflatedand thus has a higher threshold opening pressure than that of theretention balloon, and has a second wall thickness that is greater thanthe first wall thickness and a second durometer that is greater than thefirst durometer, wherein the retention balloon is configured to inflateat a first inflation pressure, and the pilot balloon is configured toinflate at a second inflation pressure that is higher than the firstinflation pressure and lower than a predetermined pressure threshold.13. The method of claim 12, further comprising forming the aperture inthe second arm.
 14. The method of claim 13, wherein forming the aperturecomprises forming at least one of a hole, a slit or a cut in the secondarm.
 15. The method of claim 12, wherein a cross-sectional area of theaperture in the second arm is less than a cross-sectional area of thedistal filling hole.
 16. The method of claim 12, further comprising:forming the tubular pilot balloon to have the tubular shape; and formingthe retention balloon to have the preformed balloon shape, wherein ahigher pressure is required to begin inflating the tubular pilot balloonthan the retention balloon.
 17. The method claim 12, further comprising:forming the retention balloon to have the first balloon wall thickness;and forming the pilot balloon to have the second balloon wall thickness.18. (canceled)
 19. The method of claim 12, further comprising: formingthe retention balloon to have a first length; and forming the pilotballoon to have a second length that is different than the first length.20. The method of claim 12, further comprising: forming the retentionballoon to have a first inflated shape; and forming the pilot balloon tohave a second inflated shape that is different than the first inflatedshape.
 21. A method of positioning a urinary catheter in a patient, themethod comprising: advancing a distal end of the urinary catheterthrough the patient's urethra; introducing inflation fluid into theurinary catheter to inflate a retention balloon at or near the distalend of the urinary catheter; observing that a pilot balloon at or near aproximal end of the urinary catheter, located outside the patient, hasinflated; waiting for at least a predefined amount of time for the pilotballoon to deflate; and if the pilot balloon deflates during thepredefined amount of time, then leave the urinary catheter in placewithin the patient; and if the pilot balloon does not deflate during thepredefined amount of time, then: removing the inflation fluid from theurinary catheter; and repositioning or removing the urinary catheter.22. The method of claim 21, wherein the predefined amount of timecomprises a range of between 3 and 30 seconds.
 23. The method of claim21, wherein the predefined amount of time comprises ten seconds.
 24. Themethod of claim 21, wherein introducing the inflation fluid comprisesinjecting the inflation fluid with a syringe attached to an inflationport at or near the proximal end of the urinary catheter.
 25. The methodof claim 24, wherein introducing the inflation fluid comprises injectingbetween 5 cc and 10 cc of the inflation fluid.
 26. The method of claim21, further comprising visualizing at least the advancing step via aradiographic imaging device and a radiopaque strip or marker on theurinary catheter.